[Federal Register Volume 64, Number 103 (Friday, May 28, 1999)]
[Proposed Rules]
[Pages 29186-29188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13625]


      

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Part VI

Department of Labor
Pension and Welfare Benefits Administration

Department of Health and Human Services
Health Care Financing Administration
_______________________________________________________________________



29 CFR Chapter XXV



45 CFR Subtitle A



Coverage for Breast Reconstruction and Related Services After a 
Mastectomy; Proposed Rule

  Federal Register / Vol. 64, No. 103 / Friday, May 28, 1999 / Proposed 
Rules  

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DEPARTMENT OF LABOR

Pension and Welfare Benefits Administration

29 CFR Chapter XXV

RIN 1210-AA75

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
45 CFR Subtitle A
RIN 0938-AJ44


Coverage for Breast Reconstruction and Related Services After a 
Mastectomy

AGENCIES: Pension and Welfare Benefits Administration, Department of 
Labor; and Health Care Financing Administration, Department of Health 
and Human Services.

ACTION: Solicitation of comments.

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SUMMARY: This document is a request for information regarding issues 
under the Women's Health and Cancer Rights Act of 1998 (WHCRA). The 
Department of Labor and the Department of Health and Human Services 
(collectively, the Departments) have received numerous inquiries from 
the public on a number of issues arising under WHCRA. Further comments 
from the public are welcome.

DATES: Comments should be submitted on or before June 28, 1999.

ADDRESSES: Written comments should be submitted with a signed original 
and 2 copies to the Pension and Welfare Benefits Administration (PWBA) 
at the address specified below. PWBA will provide copies to the 
Department of Health and Human Services for its consideration. All 
comments will be available for public inspection and copying in their 
entirety. Comments should be sent to: Health Care Task Force, Pension 
and Welfare Benefits Administration, Room N-5677, U.S. Department of 
Labor, 200 Constitution Avenue, NW, Washington, DC 20210, Attn: WHCRA 
Solicitation of Comments. Written comments may also be sent by Internet 
to the following address: [email protected].
    All comments received will be available for public inspection and 
copying at the Public Disclosure Room, Pension and Welfare Benefits 
Administration, U.S. Department of Labor, Room N-5638, 200 Constitution 
Avenue, NW, Washington, DC 20210, on Monday through Friday of each week 
from 8:30 a.m. to 4:30 p.m. Comments received timely will also be 
available for public inspection approximately 3 weeks after the end of 
the comment period, in Room 443-G of the Department of Health and Human 
Services offices at 200 Independence Avenue, SW, Washington, DC, on 
Monday through Friday of each week from 8:30 a.m. to 5 p.m. (phone 
(202) 690-7890).

FOR FURTHER INFORMATION CONTACT: Mila Kofman, Department of Labor, 
Pension and Welfare Benefits Administration, at 202-219-8671 (not a 
toll-free number); or Suzanne Long, Health Care Financing 
Administration, at 410-786-1565 (not a toll-free number) for inquiries 
regarding WHCRA.
    Customer service information. To assist consumers and the regulated 
community, the Departments have issued questions and answers concerning 
the Women's Health and Cancer Rights Act. Individuals interested in 
obtaining a copy of the Department of Labor's publication may call a 
toll free number, 800-998-7542, or access the publication on-line at 
www.dol.gov/dol/pwba, the Department of Labor's website. Questions and 
answers pertaining to WHCRA are also available on-line at www.hcfa.gov/
hipaa, HCFA's website.

SUPPLEMENTARY INFORMATION:

Background

    The Women's Health and Cancer Rights Act of 1998 (WHCRA) was 
enacted on October 21, 1998 (Pub. L. 105-277). WHCRA amended the 
Employee Retirement Income Security Act of 1974, as amended, (ERISA) 
and the Public Health Service Act (PHS Act) to provide protection for 
patients who elect breast reconstruction in connection with a 
mastectomy. WHCRA applies to both employment-based health coverage 
(group coverage) and individual (non-employment based) health 
insurance. WHCRA amended ERISA and the PHS Act by adding new 
requirements to Part 7 of Subtitle B of Title I of ERISA and to Title 
XXVII of the PHS Act. Part 7 and Title XXVII (health insurance reform 
provisions) were previously added to ERISA and the PHS Act by the 
Health Insurance Portability and Accountability Act of 1996 (HIPAA). 
While those HIPAA provisions amended the Internal Revenue Code (Code) 
as well, WHCRA did not amend the Code.
    WHCRA is intended to provide new protections for mastectomy 
patients. Group health plans and health insurance issuers, e.g., 
insurance companies or health maintenance organizations 
(HMOs),1 offering medical and surgical benefits for a 
mastectomy are subject to WHCRA.
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    \1\ WHCRA was added to the existing health insurance reform 
provisions in Part 7 of Title I of ERISA and Title XXVII of the PHS 
Act and is subject to the definitions in Part 7 and Title XXVII. The 
term group health plan is defined in 29 CFR 2590.701-2 (1997) and 45 
CFR 144.103 (1997) (``* * * an employee welfare benefit plan * * * 
to the extent that the plan provides medical care * * * to employees 
or their dependents * * * directly or through insurance, 
reimbursement, or otherwise.''). The term health insurance issuer is 
defined in 29 CFR 2590.701-2 (1997) and 45 CFR 144.103 (1997) (``* * 
* an insurance company, insurance service, or insurance organization 
(including an HMO) that is required to be licensed to engage in the 
business of insurance in a State and that is subject to State law 
that regulates insurance * * *''). These terms also apply to the 
Newborns' and Mothers' Health Protection Act and the Mental Health 
Parity Act and the regulations implementing these laws.
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    Under WHCRA, group health plans and health insurance issuers must 
provide coverage for reconstructive surgery if an individual who is 
receiving benefits in connection with a mastectomy elects breast 
reconstruction. WHCRA requires group health plans and health insurance 
issuers to provide coverage for--
     Reconstruction of the breast on which the mastectomy has 
been performed;
     Surgery and reconstruction of the other breast to produce 
a symmetrical appearance; and
     Prostheses and physical complications at all stages of a 
mastectomy, including lymphedemas.

WHCRA requires coverage to be provided in a manner determined in 
consultation with the attending physician and the patient.
    WHCRA's requirements apply only to group health plans and health 
insurance issuers that provide coverage for a mastectomy. However, 
WHCRA does not require such entities to provide coverage for a 
mastectomy. WHCRA also does not prohibit group health plans and health 
insurance issuers from imposing deductibles or coinsurance requirements 
for health benefits relating to reconstructive surgery in connection 
with a mastectomy as long as such requirements are consistent with 
those established for other benefits under the plan or coverage. 
Additionally, WHCRA does not require mastectomy patients to undergo 
reconstructive surgery.
    WHCRA also prohibits certain compensation arrangements. 
Specifically, WHCRA prohibits group health plans and health insurance 
issuers from providing incentives (monetary or otherwise) to an 
attending provider to induce such provider to provide care to an 
individual in a manner inconsistent with the law.

[[Page 29187]]

WHCRA also prohibits group health plans and health insurance issuers 
from penalizing or otherwise reducing or limiting the reimbursement of 
an attending provider because such provider provided care to an 
individual in accordance with the law. Additionally, WHCRA prohibits 
group health plans and health insurance issuers from denying a patient 
eligibility or continued eligibility to enroll or renew coverage under 
the terms of the plan or policy solely to avoid the requirements of 
WHCRA. WHCRA further requires group health plans and health insurance 
issuers to notify participants, and in the individual market, 
policyholders, of their rights under the law upon enrollment and 
annually thereafter.
    The requirements under WHCRA apply to group health plans and health 
insurance issuers offering coverage in connection with such plans, for 
plan years beginning on or after October 21, 1998 (the date of 
enactment of WHCRA). For health insurance issuers in the individual 
market, the requirements apply with respect to health insurance 
coverage offered, sold, issued, renewed, in effect, or operated in the 
individual market on or after October 21, 1998. Accordingly, the 
Departments are working actively to develop and promulgate regulations 
implementing WHCRA.

Economic Analysis/Paperwork Reduction Act Information/Regulatory 
Flexibility Act Information

    Executive Order 12866 requires that the Departments assess the 
costs and benefits of a significant rule making action and the 
alternatives considered, using the guidance provided by the Office of 
Management and Budget. These costs and benefits are not limited to the 
Federal government, but pertain to the affected public as a whole. 
Under Executive Order 12866, the Departments must also determine 
whether implementation of WHCRA will be economically significant. A 
rule that has an annual effect on the economy of $100 million or more 
is considered economically significant.
    In addition, the Regulatory Flexibility Act may require the 
Departments to prepare an analysis of the economic impact on small 
entities of proposed rules and regulatory alternatives. An analysis 
under the Regulatory Flexibility Act must generally include, among 
other things, an estimate of the number of small entities subject to 
the regulations (for this purpose, plans, employers, and issuers and, 
in some contexts small governmental entities), the expense of the 
reporting and other compliance requirements (including the expense of 
using professional expertise), and a description of any significant 
regulatory alternatives considered that would accomplish the stated 
objectives of the statute and minimize the impact on small entities. 
The Departments seek additional information from small entities 
regarding any special problems they might encounter in implementing the 
requirements of WHCRA and any regulatory guidance that might minimize 
those problems.
    The Paperwork Reduction Act requires that the Departments estimate 
how many ``respondents'' will be required to comply with any 
``collection of information'' aspects of the regulations and how much 
time and cost will be incurred as a result. A collection of information 
includes record-keeping, reporting to governmental agencies, and third-
party disclosures.
    The Departments are requesting comments that may contribute to the 
analyses that will be performed under these requirements.

Comments

    Comments have been received from the public on a number of issues 
arising under WHCRA. These comments include questions about the notice 
requirements under WHCRA. More specifically, the Departments have been 
asked what information must be included in the annual notice and the 
enrollment notice required by WHCRA. To assist the regulated community 
and individuals, the Departments are considering whether to include in 
the regulation a model notice which will describe the information that 
must be included in these notices. The model notice would include 
information on the benefits required by WHCRA and permitted deductibles 
and coinsurance limitations. Comments are invited on whether a model 
notice would be helpful.
    In addition to the questions relating to the notice requirements, 
the Departments have received questions regarding the timing of the 
requirements under WHCRA. For example, the Departments have received 
questions on whether, to what extent, and how WHCRA applies if an 
individual had a mastectomy, but not breast reconstruction, before 
changing health plans or coverage. Similarly, questions have been 
raised about whether there is a specific time period following a 
mastectomy after which WHCRA requirements no longer apply. Additional 
comments are welcome.
    The Departments have also received questions concerning how WHCRA 
would interact with State law. Under WHCRA, State law protections 
continue to apply to certain health coverage if the State law in effect 
on October 21, 1998 (date of enactment of WHCRA) ``requires coverage of 
at least the coverage of reconstructive breast surgery otherwise 
required'' by the federal requirements under WHCRA. The Departments 
have been asked which State laws would continue to apply. Additional 
questions are invited, and in particular, the Departments are 
interested in comments from State regulators on the scope of specific 
State laws.
    The Departments welcome any and all comments related to WHCRA. 
However, the Departments are particularly interested in receiving 
comments on the aforementioned questions and those related to the 
following specific topics. While the information supplied by the public 
related to these specific topics will be used to formulate overall 
policy, it will also be used for analyses under Executive Order 12866, 
Paperwork Reduction Act, and Regulatory Flexibility Act.
    Specific areas with respect to the Departments' responsibilities 
and analysis under Executive Order 12866, Paperwork Reduction Act, and 
Regulatory Flexibility Act in which the Departments are interested 
include:
    1(a). Prior to WHCRA's enactment, what proportion of group health 
plans and/or health insurance issuers had excluded, restricted, or 
limited coverage of reconstructive surgery following mastectomies?
    1(b). What specific exclusions, restrictions, or limits applied?
    1(c). Did patient cost sharing for such surgery differ from that 
for other covered benefits?
    1(d). Did coverage for such surgeries vary depending on whether 
they were performed immediately following mastectomies or later as a 
separate procedure?
    2.  How did group health plans and health insurance issuers 
covering such surgery compensate providers for their related services?
    3.  Were small group health plans more or less likely than large 
group health plans to exclude, restrict, or limit coverage for such 
surgery?
    4(a). Among group health plans and health insurance issuers 
covering such surgery at a level consistent with WHCRA, what was the 
incidence and cost of such surgery?
    4(b). Do group health plans and health insurance issuers currently 
notify participants and beneficiaries of their coverage consistent with 
WHCRA's notification requirements?

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    5(a). Among group health plans and health insurance issuers that 
must increase coverage of such surgery to comply with WHCRA, what are 
the anticipated claims or premium cost associated with that increase?
    5(b). What is the anticipated administrative cost to amend plan 
documents and/or insurance contracts?
    5(c). Will some group health plans and health insurance issuers 
make other amendments to offset WHCRA's cost?
    5(d). Will plans' costs and responses vary with plans' size?
    6.  Does the extent and nature of coverage for such surgery affect 
the likelihood that patients will elect it and/or the timing of such 
surgery?
    7.  What are the benefits of coverage for reconstructive surgery 
following mastectomy?
    The purpose of this announcement is to advise the public that 
further comments and suggestions concerning any area or issue pertinent 
to the assessment and development of regulatory guidance regarding 
WHCRA are welcome.
    All submitted comments will be made part of the official record and 
will be available for public inspection.

    Signed at Washington, DC this 17th day of March 1999.
Richard M. McGahey,
Assistant Secretary, Pension and Welfare Benefits Administration, 
Department of Labor.

    Signed at Washington, DC this 22nd day of March 1999.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration, Department of 
Health and Human Services.
[FR Doc. 99-13625 Filed 5-27-99; 8:45 am]
BILLING CODE 4510-29-P; 4120-01-P